ISO13485 - 7.3.2 Design and development input

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) functional, performance and safety requirements, according to the intended use, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, d) other requirements essential for design and development, and e) output(s) of risk management (see 7.1). These inputs shall be reviewed for adequacy and approved.

Requirements shall be complete, unambiguous and not in conflict with each other.